Presentations of Hyperandrogenic Phenotypes in Taiwanese Women
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|ClinicalTrials.gov Identifier: NCT01940666|
Recruitment Status : Completed
First Posted : September 12, 2013
Last Update Posted : November 6, 2013
|Condition or disease|
|Hyperandrogenism, Polycystic Ovary Syndrome, Metabolic Syndrome, Insulin Resistance, Cardiovascular Disease.|
STUDY DESIGN, SIZE, DURATION:A retrospective study in 160 Taiwanese women with HA and 165 women without HA, with medical records reviewed from 2009 up to 2012. The hyperandrogenic women were classified into four groups (TT, A4, FAI, and DHEA-S) according to independent abnormally elevated androgen measures each above its cut-off value, and the groups were compared with each other and with controls.
PARTICIPANTS/MATERIALS, SETTING, METHODS: This study was performed in the Reproductive Endocrinology Clinic at Wan Fang Medical Center in Taipei, Taiwan. Anthropometric, metabolic, endocrine, and IR components as well as lipid accumulation product (LAP) index were compared between the groups. IR was assessed with the following markers: fasting glucose and insulin levels, oral glucose tolerance test, glucose-to-insulin ratio and homeostasis model assessment of IR index (HOMA-IR).
|Study Type :||Observational|
|Actual Enrollment :||649 participants|
|Observational Model:||Case Control|
|Official Title:||Clinical and Biochemical Presentations of Distinctive Types of Biochemical Hyperandrogenism in Premenopausal Taiwanese Women|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||July 2013|
patients who have all androgens (TT, A4, FAI, and DHEA-S) lower than their cut-off values
Total Testosterone >= 2.39
Patients who have only total testosterone higher than its cut-off value; (TT) >=2.39
Androstenedione >= 2.99
Patients who have only androstenedione higher than its cut-off value; (A4) >=2.99
Free Androgen Index >= 6.53
Patients who have only free androgen index higher than its cut-off value; (FAI) >=6.53
DHEAs >= 181.55
Patients who have only dehyroepiandrosterone sulfate higher than its cut-off value; (DHEA-S)>=181.55
- Clinical and Biochemical Presentations of Distinctive Types of Biochemical Hyperandrogenism in Premenopausal Taiwanese Women [ Time Frame: A retrospective study in 160 Taiwanese women with HA and 165 women without HA, with medical records reviewed from January 1, 2009, through July 21, 2012 (up to 3.5 years) ]Androgens (Total Testosterone (TT) (nmol/L), androstenedione (A4)(ng/ml), free androgen index (FAI), and dehydroepiandrosterone sulfate (DHEA-S) (µg/dl ); anthroponmetric components (body mass index (BMI)(Kg/m2) , waist (cm), Waist-to-hip ratio (W/H)); average menstrual interval, antimullerian hormone(AMH)(ng/ml) adiponectin (ng/nl), leptin(ng/ml), adiponectin/leptin (A/L) ratio, and insulin resistance markers( fasting insulin (µIU/ml), glucose-to-insulin ratio (GIR), Homeostasis model assessment insulin resistance (HOMA-IR) Index, Lipid Accumulation Product Index (LAP Index)).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01940666
|WanFang Medical Center at Taipei Medical University|
|Taipei, Taiwan, 116|
|Principal Investigator:||Ming I Hsu, MD||WanFang Medical Center at Taipei Medical University|